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U.S. Department of Health and Human Services

Class 2 Device Recall RX Daytona

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  Class 2 Device Recall RX Daytona see related information
Date Initiated by Firm December 19, 2019
Date Posted February 24, 2020
Recall Status1 Terminated 3 on April 23, 2021
Recall Number Z-1349-2020
Recall Event ID 84649
510(K)Number K131554  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage:
A fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For use in clinical laboratories.
Code Information Software version UI2550642107 for the RX Daytona Plus instrument.
Recalling Firm/
Manufacturer		 Randox Laboratories, Limited
Ardmore; 55 The Diamond Road
Crumlin United Kingdom
For Additional Information Contact Nicola Moore
44-028-94422413
Manufacturer Reason
for Recall		 Software version UI2550642107 for the RX Daytona + instrument released to correct the following issues: 1) The order of samples displayed is not sequential according to SID (sample identification number) when searching the run/results screen; 2) Incorrect color flagging of IQC as "out of range."
FDA Determined
Cause 2		 Under Investigation by firm
Action Randox Medical Device Correction letter dated 12.17.2019. The recall from the manufacturer is extended to the distribution center within the USA and Puerto Rico. The distributor will then contact the customer directly. The initial contact and the follow up contact will be via email. If further contacts are required these will be via telephone. It is intended that the initial contact will be conducted 19th December 2019. The distributors and customers will be instructed to read and review the release notes and carry-out all actions specified within. Distributors are advised to contact all end-users and provide the FSN, response form and release notes. Customers were advised to take the following actions: complete and return the response form 12187-QA to technical.services@randox .com within five working days. ***Updated 3/2/2020*** The firm sent an updated customer letter on February 28, 2020, which included an updated "Risk to Health" statement, which now states that a delay in reporting results could lead to a delay in diagnosis and/or treatment. No erroneous patient results are generated due to this issue. Instructions to customers have not changed.
Quantity in Commerce U.S.: RX4040-2 units RX 4041-3 units
Distribution US Nationwide distribution including state of PR.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = RANDOX LABORATORIES, LTD.
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